Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening

NCT05714644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5127

Last updated 2025-12-26

Study results available
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Summary

The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. The main questions the project aims to answer are: What screening test has a higher completion rate? What screening test is more feasible and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail and will be asked to complete it at home and mail it back. Researchers will compare the completion rates for each screening test and will also look at the overall completion rate of both tests.

Conditions

Interventions

OTHER

FIT kit Screening Test

FIT kit mailed to the patient's home

OTHER

Cologuard Screening Test

Cologuard test mailed to the patient's home

Sponsors & Collaborators

  • Stand Up To Cancer

    collaborator OTHER
  • University of California, Los Angeles

    collaborator OTHER
  • Great Plains Tribal Leaders Health Board

    collaborator UNKNOWN
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Jennifer Haas, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-07
Primary Completion
2024-06-30
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714644 on ClinicalTrials.gov